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Clinical Trials/NCT00480662
NCT00480662
Completed
Phase 3

A 6-Month, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Alendronate 280-mg Oral Buffered Solution Once Weekly in Patients With Paget's Disease of Bone

Organon and Co0 sites60 target enrollmentOctober 2001

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Paget's Disease of Bone
Sponsor
Organon and Co
Enrollment
60
Primary Endpoint
Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months
Status
Completed
Last Updated
last year

Overview

Brief Summary

To test the safety, effectiveness of MK0217 when taken once a week for six months in treating patients with Paget's bone disease.

Registry
clinicaltrials.gov
Start Date
October 2001
End Date
October 2002
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female, ages 18 to 90 years with a diagnosis of Paget's bone disease

Exclusion Criteria

  • Patient cannot stand or sit upright for at least 30 minutes
  • Patient has difficulty swallowing or problems with digestive system

Outcomes

Primary Outcomes

Patients will have a decrease of at least 30% in their blood alkaline phosphatase level after 6 months

Secondary Outcomes

  • MK0217 will be safely tolerated

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